Evidence map›Paper›PMID 41199102›Full record

ArticleNeurocritical care2026

Informed Consent Practices in Research Involving Persons with Disorders of Consciousness.

Ariane Lewis, Saptharishi Lalgudi Ganesan, Ralf J Jox, Anna Teresa Mazzeo, Michael A Rubin, Jennifer K Walter, Michael J Young, Curing Coma Campaign and its contributing members

Abstract read
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In one paragraph

Article in Neurocritical care, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Ethical Considerations in Transcranial Focused Ultrasound Neuromodulation for Disorders of Consciousness.Neuromodulation : journal of the International Neuromodulation Society · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Ariane LewisNYU Langone Health, New York, NY, USA. ariane.kansas.lewis@gmail.com.ORCID 0000-0002-0756-7320
Saptharishi Lalgudi GanesanSchulich School of Medicine & Dentistry, Departments of Paediatrics & Clinical Neurological Sciences, Western University, London, ON, Canada.
Ralf J JoxLausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Anna Teresa MazzeoDepartment of Human Pathology, Anesthesia and Intensive Care, University of Messina, Messina, Italy.
Michael A RubinUniversity of Texas Southwestern Medical School, Dallas, TX, USA.
Jennifer K WalterDepartment of Medical Ethics, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
Michael J YoungMassachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
Curing Coma Campaign and its contributing members

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe Curing Coma Campaign Ethics Working Group sought to understand informed consent practices for research involving persons with disorders of consciousness (DoC) to establish an empirical foundation to formulate common consent elements for research regarding this vulnerable population.

methodsConsent forms for research involving persons with DoC were collected from the Curing Coma Campaign members and Clinicaltrials.gov in the fall of 2024. We abstracted data about study specifics, the consent process, and unique considerations related to persons with DoC and then reviewed and collated them using descriptive statistics.

resultsThe collection process yielded 58 consent forms: 40 (69%) from member submissions and 18 (31%) from Clinicaltrials.gov. After excluding duplicates and studies that did not pertain to persons with DoC, there were 43 forms, which included 62 unique terms to describe acute brain injury/consciousness/DoC. Of 41 studies that enrolled persons with DoC, there were 4 (10%) that mentioned an evaluation for covert consciousness. Although only 3 (7%) forms mentioned an evaluation for capacity of the person with DoC/recovered from DoC, 16 (39%) referenced first-person consent if the person with DoC regained capacity. Most studies that involved study-specific medications/interventions/tests included some mention of experiential risks (26/32, 81%), but only 2 (6%) specifically addressed the challenges associated with these risks in a person with DoC.

conclusionsConsent forms for research involving persons with DoC include inconsistent terminology to describe acute brain injury/consciousness/DoC, the capacity to consent, and the potential experiential risks of study participation in the context of a DoC. There are opportunities to improve transparency and consistency of communication about research involving persons with DoC via creation of common consent elements to ensure the informed consent process protects individual autonomy.

Indexed as

Biomedical ResearchConsciousness DisordersConsent FormsInformed ConsentHumansComaDisorders of consciousnessEthicsResearch

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.